Abstract TP9: Safety of Endovascular Treatment in Acute Stroke Patients Taking Oral Anticoagulants

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Timo Uphaus ◽  
Oliver C Singer ◽  
Joachim Berkefeld ◽  
Christian H Nolte ◽  
Georg Bohner ◽  
...  

Introduction: The endovascular treatment (EVT) of cerebral ischemia in the case of large vessel occlusion has been established over recent years. Randomized trials showed a positive impact on the clinical outcome of endovascular treatment in addition to thrombolysis with respect to clinical outcome and safety, so that this therapeutic option will be implemented in future guidelines. The role of EVT in patients treated with oral anticoagulants remains uncertain. Hypothesis: We assessed the hypothesis that application of EVT is safe with regard to the occurrence of intracranial bleeding and clinical outcome in patients taking anticoagulants. Methods: The ENDOSTROKE-Registry is a commercially independent, prospective observational study in 12 stroke centers in Germany and Austria launched in January 2011. An online tool served for data acquisition of pre-specified variables concerning endovascular stroke therapy. Results: Data from 815 patients (median age 70, 57% male) undergoing EVT and known anticoagulation status were analyzed. A total of 85 (median age 76, 52% male) patients (10.4%) took oral anticoagulants prior to EVT. Anticoagulation status as measured with INR was 2.0-3.0 in 24 patients (29%), <2.0 in 52 patients (63%) and above 3.0 in 7 patients (8%) of 83 patients with valid INR data prior to EVT. Patients taking anticoagulants were significantly older (median age 76 vs. 69, p < 0.001). Comparing those patients taking anticoagulants and those not, there were no differences concerning NIHSS at admission (with anticoagulants Median-NIHSS 17 vs. without Median-NIHSS 15, p = 0.492, Mann Whitney Test) and the rate of intracranial hemorrhage after intervention (with anticoagulants 11.8% vs. without 12.2%, p = 0.538). After adjustment for age and NIHSS at admission there were no significant differences between the two groups with regard to good clinical outcome, as measured with the modified ranking scale (mRS, 90d-mRS 0-2, 39.2% of patients not receiving anticoagulants; 25.9% of those receiving anticoagulants). Conclusion: The application of endovascular treatment in patients taking oral anticoagulants is safe and should be considered in acute stroke treatment as an important alternative to contraindicated intravenous thrombolysis.

Author(s):  
Juha-Pekka Pienimäki ◽  
Jyrki Ollikainen ◽  
Niko Sillanpää ◽  
Sara Protto

Abstract Purpose Mechanical thrombectomy (MT) is the first-line treatment in acute stroke patients presenting with large vessel occlusion (LVO). The efficacy of intravenous thrombolysis (IVT) prior to MT is being contested. The objective of this study was to evaluate the efficacy of MT without IVT in patients with no contraindications to IVT presenting directly to a tertiary stroke center with acute anterior circulation LVO. Materials and Methods We collected the data of 106 acute stroke patients who underwent MT in a single high-volume stroke center. Patients with anterior circulation LVO eligible for IVT and directly admitted to our institution who subsequently underwent MT were included. We recorded baseline clinical, laboratory, procedural, and imaging variables and technical, imaging, and clinical outcomes. The effect of intravenous thrombolysis on 3-month clinical outcome (mRS) was analyzed with univariate tests and binary and ordinal logistic regression analysis. Results Fifty-eight out of the 106 patients received IVT + MT. These patients had 2.6-fold higher odds of poorer clinical outcome in mRS shift analysis (p = 0.01) compared to MT-only patients who had excellent 3-month clinical outcome (mRS 0–1) three times more often (p = 0.009). There were no significant differences between the groups in process times, mTICI, or number of hemorrhagic complications. A trend of less distal embolization and higher number of device passes was observed among the MT-only patients. Conclusions MT without prior IVT was associated with an improved overall three-month clinical outcome in acute anterior circulation LVO patients.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Pedro Cardona ◽  
Helena Quesada ◽  
Luis Cano ◽  
Lucia Aja ◽  
De Miquel MA. ◽  
...  

In our comprehensive stroke center we analyze correct selection criteria to use self-expandable retrievable intracranial stents for acute stroke treatment. The criteria for intervention were the onset of neurological symptoms, a National Institute of Health Stroke Scale Score (NIHSS) ≥9 at presentation, large vessel occlusion stroke demonstrated by angio-CT, and failure of intravenous thrombolysis or exclusion criteria to administrate it. METHODS: We performed an retrospective analysis of 512 consecutive patients with acute ischemic stroke candidates for thrombectomy, from April of 2010 to June of 2012, that met inclusion criteria for intervention. Experienced vascular neurologists selected 171 patients to undergoing endovascular therapy using retrievable stents (Solitaire,Trevo). Successful recanalization results were assessed by follow-up angiography immediately after the procedure (TIMI 2-3/TICI 2b-3 score), and good functional outcome was considered when ≤2 mRankin score (mRS) was achieved at 90 days. RESULTS: A total of 171 patients were treated, 87% with anterior circulation stroke. The mean age was 67.5 years (range 32-87); 58% men. The median NIHSS at presentation was 17 (range 6-26). Recanalization (TICI 2b-3) was achieved in 73% of patients. Symptomatic hemorrhage occurred in 8%. Ninety-day mortality was 19, 5% and good 90-day functional outcome (mRS ≤2) was achieved by 45%. Unsuccessful recanalization (TICI 0-2a) was a significant predictor of poor outcome (mRS≤2: 9%). When we analyzed these patients according to inclusion criteria of IMS trial, 101 patients who met strict criteria achieved good neurological outcome more frequently (51% versus 34%) and significant lower mortality rates (17% vs 28%) compared with the group of 70 patients with IMS exclusion criteria. CONCLUSIONS: Efficacy in recanalization, safety of thrombectomy and its consequent good clinical outcome is sufficiently established. It is important an experienced vascular neurologist to select possible candidates (proportion of evaluated/treated patients 3:1). Inclusion criteria for acute stroke trials do not always represent real population of stroke patients as well as their clinical results.


2021 ◽  
Vol 92 (5) ◽  
pp. 534-541
Author(s):  
David J Seiffge ◽  
Thomas Meinel ◽  
Jan Christoph Purrucker ◽  
Johannes Kaesmacher ◽  
Urs Fischer ◽  
...  

Direct oral anticoagulants (DOACs) have emerged as primary therapeutic option for stroke prevention in patients with atrial fibrillation. However, patients may have ischaemic stroke despite DOAC therapy and there is uncertainty whether those patients can safely receive intravenous thrombolysis or mechanical thrombectomy. In this review, we summarise and discuss current knowledge about different approaches to select patient. Time since last DOAC intake—as a surrogate for anticoagulant activity—is easy to use but limited by interindividual variability of drug pharmacokinetics and long cut-offs (>48 hours). Measuring anticoagulant activity using drug-specific coagulation assays showed promising safety results. Large proportion of patients at low anticoagulant activity seem to be potentially treatable but there remains uncertainty about exact safe cut-off values and limited assay availability. The use of specific reversal agents (ie, idarucizumab or andexanet alfa) prior to thrombolysis is a new emerging option with first data reporting safety but issues including health economics need to be elucidated. Mechanical thrombectomy appears to be safe without any specific selection criteria applied. In patients on DOAC therapy with large vessel occlusion, decision for intravenous thrombolysis should not delay thrombectomy (eg, direct thrombectomy or immediate transfer to a thrombectomy-capable centre recommended). Precision medicine using a tailored approach combining clinicoradiological information (ie, penumbra and vessel status), anticoagulant activity and use of specific reversal agents only if necessary seems a reasonable choice.


2017 ◽  
Vol 7 (1-2) ◽  
pp. 42-47 ◽  
Author(s):  
Andreia Carvalho ◽  
André Cunha ◽  
Tiago Gregório ◽  
Ludovina Paredes ◽  
Henrique Costa ◽  
...  

Background: Several reports refer to differences in stroke between females and males, namely in incidence and clinical outcome, but also in response to treatments. Driven by a recent analysis of the MR CLEAN trial, which showed a higher benefit from acute stroke endovascular treatment (EVT) in males, we intended to determine if clinical outcomes after EVT differ between sexes, in a real-world setting. Methods: We analyzed 145 consecutive patients submitted to EVT for anterior circulation large-vessel occlusion, between January 2015 and September 2016, and compared the outcomes between sexes. Results: Our population was represented by 81 (55.9%) females, with similar baseline characteristics (pre-stroke disability, baseline NIHSS, and ASPECTS), rate of previous intravenous thrombolysis, time from onset to recanalization, and rate of revascularization; with the exception that women were on average 4 years older and had more hypertension, and men in turn had more tandem occlusions and atherosclerotic etiology (all p < 0.05). Even after adjusting for these statistically significant variables and for intravenous thrombolysis (as some studies advocate a different response to this treatment between sexes), there were no differences in intracranial hemorrhage, functional independence (mRS ≤2 in 60.9% males vs. 66.7% in females, p = 0.48; adjusted p = 0.36), or mortality at 3 months. Conclusion: In a real-world setting, we found no sex differences in clinical and safety outcomes after acute stroke EVT. Our results support the idea that women are equally likely to achieve good outcomes as men after acute stroke EVT.


Neurology ◽  
2021 ◽  
pp. 10.1212/WNL.0000000000012390
Author(s):  
Aristeidis Katsanos ◽  
Guillaume Turc ◽  
Marios Psychogios ◽  
Johannes Kaesmacher ◽  
Lina Palaiodimou ◽  
...  

Objective:To provide a critical appraisal on the evidence from randomized-controlled clinical trials (RCTs) on the utility of direct endovascular treatment (dEVT) compared to the combination of endovascular treatment preceded by intravenous thrombolysis (bridging therapy, BT) for patients with acute large vessel occlusion (LVO).Methods:Eligible RCTs were identified by searching Medline and Scopus. We calculated the corresponding odds ratios (ORs) and 95% confidence intervals (95%CI) and pooled estimates using random-effects models. The primary outcome was the probability of modified Rankin scale (mRS) score of 0-2 at 3 months.Results:We included 3 studies comprising 1092 patients. No difference between dEVT and BT groups was detected for the outcomes of mRS 0-2 (OR=1.08,95%CI:0.85-1.38; adjusted OR=1.11, 95%CI:0.76-1.63), mRS 0-1 (OR=1.10, 95%CI:0.84-1.43; adjusted OR=1.16, 95%CI:0.84-1.61) and functional improvement at 3 months (common OR=1.08, 95%CI:0.88-1.34; adjusted common OR=1.09, 95%CI:0.86-1.37). Patients receiving dEVT had significantly lower likelihood of successful recanalization prior to the endovascular procedure compared to BT (OR=0.37, 95%CI:0.18-0.77). Patients receiving dEVT had lower intracranial bleeding rates compared to those receiving BT (OR=0.67, 95%CI:0.49-0.92), however, without significant difference in the probability of symptomatic intracranial hemorrhage. No differences in all-cause mortality, serious adverse events or procedural complications between the two groups were uncovered.Conclusions:We detected no differences in functional outcomes of IV thrombolysis eligible patients with an acute LVO receiving dEVT compared to BT. Since uncertainty for most endpoints remains large and the available data is not able to exclude the possibility of overall benefit or harm, further RCTs are needed.


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
K Piayda ◽  
M Hornung ◽  
I Grunwald ◽  
K Sievert ◽  
S Bertog ◽  
...  

Abstract Background Endovascular treatment for acute stroke with large vessel occlusion became the mainstay therapy but remains limited due to lack of trainees and specialized centers. To offer this therapeutical option to a vast population, interventional cardiologists joined interdisciplinary stroke teams. Because of limited experience, it remains unclear if the timing of the procedure (i.e., regular hours vs. on-call time) may influence quality, time-effectiveness and outcomes. Purpose To investigate if the timing of the procedure (i.e., regular hours vs. on-call time) significantly influences procedural parameters and outcomes of patients undergoing acute endovascular stroke treatment. Methods Consecutive patients undergoing acute endovascular stroke treatment from 07/2012 – 10/2020, treated by cardiologists, were reviewed. Baseline characteristics, procedural aspects and clinical outcomes were retrospectively collected. Cases were divided into two groups, depending on the timing of the procedure: on-call time (OC, i.e., weekend days, public holidays and documented “call in” of the on-call service) vs. regular hours (RH, i.e., all other procedures) and outcomes subsequently compared. Results One-hundred-thirteen consecutive patients underwent endovascular treatment for acute stroke; of those 77 (68.1%) during regular hours and 36 (31.9%) during on-call time. Patients were in their early 70ies and risk factors such as arterial hypertension, diabetes mellitus, dyslipidemia and atrial fibrillation were evenly distributed. Modified Ranking Scale (mRS) at presentation was 5 in both groups and decreased to 3 at discharge. The anterior circulation was most often affected (RH: 90.9% vs. OC: 94.4%, p=0.518) and a stent retriever only strategy commonly chosen (RH: 42.8% vs. OC: 30.5%, p=0.211), followed by a combined approach of stent retriever use and aspiration (RH: 25.9% vs. OC: 27.7%, p=0.752). Door-to-needle time (RH: 0:55h IQR [0:45–1:22] vs. OC: 1:05h IQR [0:54–1:30], p=0.237) and procedure duration (RH: 0:48h IQR [0:30–1:25] vs. OC: 0:58h IQR [0:35–1:46], p=0.214) were comparable. Contrast agent use and radiation time (RH: 17.6 min IQR [11.7–29.3] vs. OC: 17.6 min IQR [12.1–33.6]) did not differ between groups, however patients in the OC group experienced a higher dose area product (RH: 4827mGy cm2 IQR [1567–14092] vs. 12727mGy cm2 [6732–18889], p&lt;0.001). The combined quality endpoint, comprising of TICI IIb/III flow after the procedure, no embolization to new territory and no symptomatic intracranial bleeding during in hospital stay was met in 85.5% of patients in the RH group and 80.5% of the on-call group (p=0.485). Death during in-hospital stay was observed in 22% of patients in the RH group and 11.1% of the OC group (p=0.163). Conclusions Endovascular intervention for acute stroke treatment during on-call time is as effective and safe as if performed during regular hours but associated with a higher dose area product. FUNDunding Acknowledgement Type of funding sources: None.


2016 ◽  
Vol 11 (5) ◽  
pp. 544-548 ◽  
Author(s):  
Andreas Kastrup ◽  
Freimuth Brunner ◽  
Katrin Wasser ◽  
Helmut Hildebrandt ◽  
Christoph Roth ◽  
...  

Background In patients with large vessel occlusions, endovascular treatment has been shown to be superior to intravenous thrombolysis in recent trials. Aims The aim of this study was to analyze the impact of endovascular treatment on clinical and radiological outcome in everyday clinical practice. Methods We compared the rates of good outcome (modified Rankin scale ≤ 2 at discharge), in-hospital death, symptomatic intracranial hemorrhages, and infarct sizes in patients with distal intracranial carotid artery, M1 and M2 occlusions during two time periods. Results From January 2008 to October 2012, a total of 509 patients were treated with intravenous thrombolysis and from November 2012 to December 2014, a total of 270 patients received endovascular treatment with stent retrievers (with or without intravenous thrombolysis). Significantly, more patients in the endovascular treatment group than in the intravenous thrombolysis group had a good outcome (37% vs. 27%, p < 0.01). The infarct sizes were significantly smaller after endovascular treatment than intravenous thrombolysis, whereas the symptomatic intracranial hemorrhages rates and in-hospital mortality were comparable between both treatment groups. The positive impact of endovascular treatment on clinical outcome was most pronounced in patients ≥75 years (31% endovascular treatment vs. 19% intravenous thrombolysis, p < 0.01), in patients with M1 occlusions (43% endovascular treatment vs. 25% intravenous thrombolysis, p < 0.01) and in patients with an admission National Institutes of Health Stroke Scale ≥ 14 (24% endovascular treatment vs. 11% intravenous thrombolysis, p < 0.05). Conclusion In everyday clinical practice and compared with intravenous thrombolysis, endovascular treatment significantly improved clinical outcome and was associated with smaller infarctions. This beneficial effect appeared to be highest in older patients, more severely affected patients, and in those with M1 occlusions.


2019 ◽  
Vol 48 (3-6) ◽  
pp. 115-123
Author(s):  
Carmen Serna Candel ◽  
Marta Aguilar Pérez ◽  
Victoria Hellstern ◽  
Muhammad AlMatter ◽  
Hansjörg Bäzner ◽  
...  

Background: According to a recent meta-analysis, 1 out of 10 patients with emergent large intracranial vessel occlusion (ELVO) causing stroke have recanalization after intravenous thrombolysis (IVT) alone. However, rate, clinical outcome, and recanalization pattern of this phenomenon are poorly understood. Objectives and Methods: Patients with ELVO recanalized only by IVT were analyzed, and frequency of recanalization, clinical outcome, safety variables, and reperfusion pattern were assessed. These patients were compared to a group of patients with ELVO who underwent endovascular thrombectomy with or without prior IVT. Results: Successful or sufficient recanalization after IVT alone occurred in 81 of 760 patients (10.6%) with ELVO who had been referred for endovascular thrombectomy. These 81 patients (group 1) were compared to a group of patients receiving endovascular thrombectomy with prior IVT (group 2) or without (group 3). A good clinical outcome at 90 days was seen in 61.7% of patients in group 1, 32.2% in group 2, and 34.5% in group 3 (p < 0.001). The 3 groups had no significant differences in intracranial hemorrhage. IVT was not independently associated with symptomatic intracranial hemorrhage, parenchymal hematoma, or subarachnoid hemorrhage. Mortality at 90 days was 9.9% in group 1, 20.7% in group 2, and 29.6% in group 3 (p < 0.001). After adjusting for all relevant variables, outcome and mortality differences were nonsignificant. No difference in the rate of successful reperfusion (modified treatment in cerebral ischemia [mTICI] 2b/3) was found. A reperfusion mTICI 3 was achieved in 18.5% in group 1, 60.7% in group 2, and 57.1% in group 3 (p < 0.001). Patients in group 1 had lower chance of achieving a complete recanalization (mTICI 3) compared to patients in group 2, OR 0.15 (95% CI 0.08–0.29) and in group 3, OR 0.17 (95% CI 0.09–0.32; p < 0.001). Conclusions: Primary IVT in ELVO caused a recanalization rate of 10.6%, making endovascular treatment either unnecessary or impossible. Early recanalization of ELVO with only IVT is associated with a 61.7% independence rate at 90 days and similar successful reperfusion rates (mTICI2b/3) compared to ELVO treated with endovascular treatment, with or without previous IVT. However, recanalization only through IVT achieves a lower rate of mTICI 3 reperfusion when compared to endovascular treatment.


2021 ◽  
pp. 197140092110091
Author(s):  
Hanna Styczen ◽  
Matthias Gawlitza ◽  
Nuran Abdullayev ◽  
Alex Brehm ◽  
Carmen Serna-Candel ◽  
...  

Background Data on outcome of endovascular treatment in patients with acute ischaemic stroke due to large vessel occlusion suffering from intravenous thrombolysis-associated intracranial haemorrhage prior to mechanical thrombectomy remain scarce. Addressing this subject, we report our multicentre experience. Methods A retrospective analysis of consecutive acute ischaemic stroke patients treated with mechanical thrombectomy due to large vessel occlusion despite the pre-interventional occurrence of intravenous thrombolysis-associated intracranial haemorrhage was performed at five tertiary care centres between January 2010–September 2020. Baseline demographics, aetiology of stroke and intracranial haemorrhage, angiographic outcome assessed by the Thrombolysis in Cerebral Infarction score and clinical outcome evaluated by the modified Rankin Scale at 90 days were recorded. Results In total, six patients were included in the study. Five individuals demonstrated cerebral intraparenchymal haemorrhage on pre-interventional imaging; in one patient additional subdural haematoma was observed and one patient suffered from isolated subarachnoid haemorrhage. All patients except one were treated by the ‘drip-and-ship’ paradigm. Successful reperfusion was achieved in 4/6 (67%) individuals. In 5/6 (83%) patients, the pre-interventional intracranial haemorrhage had aggravated in post-interventional computed tomography with space-occupying effect. Overall, five patients had died during the hospital stay. The clinical outcome of the survivor was modified Rankin Scale=4 at 90 days follow-up. Conclusion Mechanical thrombectomy in patients with intravenous thrombolysis-associated intracranial haemorrhage is technically feasible. The clinical outcome of this subgroup of stroke patients, however, appears to be devastating with high mortality and only carefully selected patients might benefit from endovascular treatment.


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